研究者詳細 - 北郷　実

論文 - 北郷　実

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New criteria for preoperative liver function assessment with safety margins to avoid postoperative mortality during liver resection for hilar cholangiocarcinoma.

Kojima H, Abe Y, Udagawa D, Hayashi K, Chiba N, Imai S, Mihara K, Higashi H, Odaira M, Oshima G, Koizumi W, Kitago M, Yagi H, Hasegawa Y, Hori S, Tanaka M, Nakano Y, Kawachi S, Kitagawa Y

HPB : the official journal of the International Hepato Pancreato Biliary Association 27 （ 2 ） 159 - 166 2025年02月

ISSN 1365-182X

Background: Despite recent medical advancements, surgery for hilar cholangiocarcinoma is associated with high complication and mortality rates. This may be partly attributed to the absence of established preoperative liver evaluation criteria for safe surgery. This study aimed to propose a reliable indicator for safe and well-planned management of major hepatectomy with extrahepatic bile duct resection. Methods: We included 150 patients who underwent major hepatectomy with extrahepatic bile duct resection between 2013 and 2021 in Japan. The risk factors for post-hepatectomy liver failure (PHLF) were retrospectively analyzed. Results: PHLF was observed in 24 (16.0 %) patients who underwent major hepatectomy with extrahepatic bile duct resection. In the multivariate analysis, the identified risk factors for PHLF were the ratio of future remnant liver volume to total liver volume (FRLV/TLV) ≤ 42 % and indocyanine green clearance fraction of the future remnant liver (ICGK-F) ≤ 0.07. Patients with these two factors were significantly associated with PHLF compared with those with either one or none of the risk factors (60.0 % vs 15.1 % and 8.1 %, respectively). Conclusion: The combinational use of ICGK-F and FRLV/TLV is useful for preoperative liver function assessment with a safety margin to avoid PHLF and postoperative mortality in hepatectomy for hilar cholangiocarcinoma.

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A Composite Endpoint of Liver Surgery (CELS): Development and Validation of a Clinically Relevant Endpoint Requiring a Smaller Sample Size.

Kawashima J, Akabane M, Endo Y, Woldesenbet S, Khalil M, Sahara K, Ruzzenente A, Aldrighetti L, Bauer TW, Marques HP, Lopes R, Oliveira S, Martel G, Popescu I, Weiss MJ, Kitago M, Poultsides G, Sasaki K, Maithel SK, Hugh T, Gleisner A, Aucejo F, Pulitano C, Shen F, Cauchy F, Groot Koerkamp B, Endo I, Pawlik TM

Annals of surgical oncology 2025年01月

ISSN 1068-9265

Background: The feasibility of trials in liver surgery using a single-component clinical endpoint is low because single endpoints require large samples due to their low incidence. The current study sought to develop and validate a novel composite endpoint of liver surgery (CELS) to facilitate the generation of more feasible and robust high-level evidence in the field of liver surgery. Methods: Patients who underwent curative-intent hepatectomy for hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or colorectal liver metastasis were identified using a multi-institutional database. Components of CELS were selected based on perioperative liver surgery-specific complications using univariable logistic regression models. The association of CELS with prolonged length of stay (LOS) and surgery-related death was evaluated and externally validated. Sample sizes were calculated for both individual outcomes and CELS. Results: Among 1958 patients, 377 (19.3%) met CELS criteria based on postoperative bile leak (n = 221, 11.3%), post-hepatectomy liver failure (n = 71, 3.6%), post-hepatectomy hemorrhage (n = 38, 1.9%), or intraoperative blood loss of 2000 ml or greater (n = 101, 5.2%). CELS demonstrated favorable discriminative accuracy of surgery-related death (analytic cohort: area under the curve [AUC], 0.79 vs external validation cohort: AUC, 0.85). In addition LOS was longer among the patients with a positive CELS (analytic cohort: 14 vs. 9 days [p < 0.001] vs. the validation cohort: 10 vs. 6 days [p < 0.001]). Relative to individual endpoints, CELS allowed a 45.8–91.6% reduction in sample size. Conclusion: CELS effectively predicted surgery-related death and can be used as a standardized, clinically relevant endpoint in prospective trials, facilitating smaller sample sizes and enhancing feasibility compared with single quality outcome metrics.

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"Biological R2" resection for intrahepatic cholangiocarcinoma: identification of patients at risk for poor oncologic outcomes after curative-intent resection.

Kawashima J, Endo Y, Woldesenbet S, Khalil M, Akabane M, Cauchy F, Shen F, Maithel S, Popescu I, Kitago M, Weiss MJ, Martel G, Pulitano C, Aldrighetti L, Poultsides G, Ruzzente A, Bauer TW, Gleisner A, Marques H, Groot Koerkamp B, Endo I, Pawlik TM

HPB : the official journal of the International Hepato Pancreato Biliary Association 2025年01月

ISSN 1365-182X

Introduction: We sought to define a cohort of patients with “biological R2” (bR2) resection, defined as recurrence within 12 weeks, following curative-intent resection for intrahepatic cholangiocarcinoma (ICC). In addition, we sought to identify factors associated with bR2 risk. Methods: Patients who underwent upfront curative-intent surgery for ICC were identified from an international, multi-institutional database. The weighted beta-coefficients of preoperative risk factors were used to construct an online tool to predict bR2. Results: Among 1138 patients, 106 (9.3 %) patients had a bR2 resection. Patients with bR2 were more likely to be younger (OR 0.97) and non-White (OR 2.19), as well as more often had cirrhosis (OR 2.11), a higher neutrophil-to-lymphocyte ratio (OR 1.07), a higher tumor burden score (OR 1.16), and metastatic nodal disease on preoperative imaging (OR 1.92). Patients categorized as low-risk had a 3.2 % risk of bR2, intermediate-risk patients had an 11.1 % risk of bR2, whereas patients in the high-risk category had a 27.6 % risk of bR2 (p < 0.001). An online tool was made available at https://junkawashima.shinyapps.io/bR2_ICC/, https://junkawashima.shinyapps.io/CRLMfollwingchemotherapy/. Conclusions: Approximately one in ten patients with resectable ICC had a bR2 resection. An online calculator can may help clinicians identify patients with ICC at highest risk of a bR2 resection.

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Up-front resection for hepatocellular carcinoma: Assessing futility in the preoperative setting.

Altaf A, Khalil M, Akabane M, Rashid Z, Kawashima J, Zindani S, Ruzzenente A, Ratti F, Marques H, Cauchy F, Lam V, Poultsides G, Aucejo F, Kitago M, Popescu I, Martel G, Gleisner A, Bauer TW, Hugh T, Bhimani N, Shen F, Endo I, Pawlik TM

European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology 51 （ 5 ） 109594 2025年01月

ISSN 0748-7983

Objective: We sought to develop a predictive model to preoperatively identify patients with hepatocellular carcinoma (HCC) at risk of undergoing futile upfront liver resection (LR). Methods: Patients undergoing curative-intent LR for HCC were identified from a large multi-institutional database. Futile LR was defined by death or disease recurrence within six months postoperatively. Backward logistic regression was performed to identify factors associated with futility. Additionally, binary criteria were established for surgical candidacy, aiming to keep the likelihood of futility below 20 %. Results: Among 1633 patients with HCC, 264 (16.2 %) underwent futile upfront LR. Tumor burden score (TBS) (coefficient: 0.083, 95%CI: 0.067–0.099), alpha-fetoprotein (AFP) (coefficient: 0.254, 95%CI: 0.195–0.310), and albumin-bilirubin (ALBI) grade 2/3 (coefficient: 0.566, 95%CI: 0.420–0.718) were independently associated with an increased risk of futile LR. The model demonstrated strong discrimination and calibration in both derivation and validation cohorts. Low, intermediate, and high-risk groups were determined based on the risk model, each with an escalating likelihood of futility, worse histological features, and worse survival outcomes. Six distinct conditions based on AFP-adjusted-to-TBS criteria were established, all with a futility likelihood of less than 20 %. Patients fulfilling these criteria had significantly better long-term recurrence-free and overall survival. The futility risk model was made available online for wide clinical applicability: (https://altaf-pawlik-hcc-futilityofsurgery-calculator.streamlit.app/). Conclusion: A preoperative risk model and AFP-adjusted-to-TBS criteria were developed and validated to predict the likelihood of futile LR among patients with HCC. This pragmatic clinical tool may assist clinicians in preoperative decision-making, helping them avoid futile surgery unlikely to offer long-term benefits.

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Chronological changes in etiology, pathological and imaging findings in primary liver cancer from 2001 to 2020.

Tsuzaki J, Ueno A, Masugi Y, Tamura M, Yamazaki S, Matsuda K, Kurebayashi Y, Sakai H, Yokoyama Y, Abe Y, Hayashi K, Hasegawa Y, Yagi H, Kitago M, Jinzaki M, Sakamoto M

Japanese journal of clinical oncology 2025年01月

ISSN 0368-2811

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Vessels encapsulating tumor clusters contribute to the intratumor heterogeneity of HCC on Gd-EOB-DTPA-enhanced MRI.

Matsuda K, Ueno A, Tsuzaki J, Kurebayashi Y, Masugi Y, Yamazaki K, Tamura M, Abe Y, Hasegawa Y, Kitago M, Jinzaki M, Sakamoto M

Hepatology communications 9 （ 1 ） 2025年01月

Background: Vessels encapsulating tumor clusters (VETC) pattern is tumor vasculature of HCC and is a predictor of prognosis and therapeutic efficacy. Recent radiological studies have demonstrated the predictability of VETC from preoperative images, but the mechanisms of image formation are not elucidated. This study aims to determine the relationship between VETC and intratumor heterogeneity in Gd-EOB-DTPA-enhanced magnetic resonance imaging (EOB-MRI) and to provide its pathological evidence. Methods: Radiologists visually classified preoperative arterial- and hepatobiliary-phase EOB-MRI images of 204 surgically resected HCCs into patterns based on heterogeneity and signal intensity; these classifications were validated using texture analysis. Single and multiplex immunohistochemistry for CD34, h-caldesmon, and OATP1B3 were performed to evaluate VETC, arterial vessel density (AVD), and OATP1B3 expression. Recurrence-free survival was assessed using the generalized Wilcoxon test. The contribution of clinicoradiological factors to the prediction of VETC was evaluated by random forest and least absolute shrinkage and selection operator regression. Results: VETC was frequently found in tumors with arterial-phase heterogeneous hyper-enhancement patterns and in tumors with hepatobiliary-phase heterogeneous hyperintense/isointense patterns (HBP-Hetero). AVD and OATP1B3 expression positively correlated with signal intensity in the arterial and hepatobiliary phases, respectively. Intratumor spatial analysis revealed that AVD and OATP1B3 expression were lower in VETC regions than in tumor regions without VETC. Patients with HBP-Hetero tumors had shorter recurrence-free survival. Machine learning models highlighted the importance of serum PIVKA-II, tumor size, and enhancement pattern of arterial and hepatobiliary phase for VETC prediction. Conclusions: VETC is associated with local reductions of both AVD and OATP1B3 expression, likely contributing to heterogeneous enhancement patterns in EOB-MRI. Evaluation of the arterial and hepatobiliary phases of EOB-MRI would enhance the predictability of VETC.

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Laparoscopic Donor Left Lateral Sectionectomy Using the Glissonean Pedicle Approach: Technical Details With Video.

Hasegawa Y, Abe Y, Obara H, Yamada Y, Kitago M, Fujino A, Kitagawa Y

Asian journal of endoscopic surgery 18 （ 1 ） e70043 2025年01月

ISSN 1758-5902

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Efficacy and safety of neoadjuvant S-1-based chemoradiotherapy in resectable and borderline-resectable pancreatic cancer: a long-term follow-up study.

Shimane G, Kitago M, Endo Y, Aiura K, Yagi H, Abe Y, Hasegawa Y, Hori S, Tanaka M, Nakano Y, Fukada J, Masugi Y, Kitagawa Y

World journal of surgical oncology 22 （ 1 ） 336 2024年12月

Background/objectives: This study aimed to evaluate the safety, efficacy, and long-term outcomes of S-1-based neoadjuvant chemoradiotherapy (NACRT) in patients with resectable or borderline-resectable pancreatic ductal adenocarcinoma (PDAC). Methods: This retrospective study included patients with PDAC who underwent S-1-based NACRT at our institute between 2010 and 2017. Results: Forty patients were included in the study, including 15 (37.5%) with resectable PDAC and 25 (62.5%) with borderline-resectable PDAC. The NACRT completion and resection rates were 85.0% (n = 34) and 67.5% (n = 27), respectively. Several grade 3 adverse events were observed, including leukopenia (25.0%), anorexia (17.5%), neutropenia (10.0%), thrombocytopenia (7.5%), febrile neutropenia (2.5%), elevated aspartate aminotransferase/alanine aminotransferase (2.5%) levels, and hyponatremia (2.5%). The R0 resection rate was 70.4% (n = 19/27) in patients who underwent pancreatectomy. Grades 1, 2, and 3 according to the College of American Pathologists grading system were observed in 1 (3.7%), 12 (44.4%), and 14 (51.9%) patients, respectively. Over a median follow-up period of 32.9 months (interquartile range, 9.1–68.0), the 1-, 3-, and 5-year OS rates were 81.4%, 45.5%, and 30.3%, respectively, in the intention-to-treat analysis. In the curative-intent surgery cohort (n = 27), the 1-, 3-, and 5-year OS rates were 88.9%, 48.2%, and 37.0%, respectively. Conclusions: S-1-based NACRT is safe and yields acceptable long-term outcomes for patients with resectable or borderline-resectable PDAC.

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Machine learning based prediction model for bile leak following hepatectomy for liver cancer.

Altaf A, Munir MM, Khan MMM, Rashid Z, Khalil M, Guglielmi A, Ratti F, Aldrighetti L, Bauer TW, Marques HP, Martel G, Alexandrescu S, Weiss MJ, Kitago M, Poultsides G, Maithel SK, Pulitano C, Lam V, Popescu I, Gleisner A, Hugh T, Shen F, Cauchy F, Koerkamp BG, Endo I, Pawlik TM

HPB : the official journal of the International Hepato Pancreato Biliary Association 2024年12月

ISSN 1365-182X

Objective: We sought to develop a machine learning (ML) preoperative model to predict bile leak following hepatectomy for primary and secondary liver cancer. Methods: An eXtreme Gradient Boosting (XGBoost) model was developed to predict post-hepatectomy bile leak using data from the ACS-NSQIP database. The model was externally validated using data from hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC) multi-institutional databases. Results: Overall, 20,570 and 2253 patients were identified from the ACS-NSQIP and multi-institutional databases, respectively. The incidence rates of bile leak were 7.0 %, 6.3 % and 10.2 % in the ACS-NSQIP, HCC and ICC databases, respectively. The XGBoost model achieved areas under receiver operating characteristic curves (AUROC) of 0.748, 0.719 and 0.711 in the training, testing and external validation cohorts, respectively. The SHAP algorithm demonstrated that the factors most strongly predictive of postoperative bile leak were serum alkaline phosphatase, surgical approach and cancer diagnosis. An online tool was developed for ease-of-use and clinical applicability (https://altaf-pawlik-bileleak-calculator.streamlit.app/). Conclusion: A novel ML model demonstrated strong discrimination power to preoperatively identify patients at high risk of developing bile leak post-hepatectomy. The online calculator may be used as a clinical tool to inform preoperative surgical planning, intraoperative decision-making, and postoperative recovery protocols for patients undergoing hepatectomy.

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Spatial Dynamics of T- and B-Cell Responses Predicts Clinical Outcome of Resectable and Unresectable Hepatocellular Carcinoma.

Kurebayashi Y, Sugimoto K, Tsujikawa H, Matsuda K, Nomura R, Ueno A, Masugi Y, Yamazaki K, Effendi K, Takeuchi H, Itoi T, Hasegawa Y, Abe Y, Kitago M, Ojima H, Sakamoto M

Clinical cancer research : an official journal of the American Association for Cancer Research 30 （ 24 ） 5666 - 5680 2024年12月

ISSN 1078-0432

Purpose: Immunotherapies have led to a paradigm shift in the treatment of hepatocellular carcinoma (HCC). Studies have revealed the single-cell catalogs of tumor-infiltrating immune cells and the trajectories of their differentiation. Nevertheless, the spatial distribution of these immune cells with distinct phenotypes in the tumor microenvironment and their clinicopathologic significance in resectable and unresectable HCCs are still largely unclear. Experimental Design: We analyzed the spatial dynamics of intratumoral CD4 and CD8 T cells and their association with B and plasma cells using 283 surgically resected HCC samples, 58 unresectable HCC samples before combined immunotherapy [atezolizumab plus bevacizumab (Atezo + Bev)], and autopsy specimens from 50 cases of advanced-stage HCC through multiplex IHC combined with transcriptomic and driver gene mutation analyses. Classification based on the spatial dynamics of T- and B-cell responses (refined immunosubtype) was developed, and its clinicopathologic significance was analyzed. Results: We found that stem-like CD4 and CD8 T cells were mainly observed in T-cell aggregates and T-cell zone of tertiary lymphoid structure (TLS). The differentiation of T follicular helper cells was associated with the development of TLS, whereas the differentiation of CXCL13-expressing CD4 TCXCL13 cells with a phenotype resembling T peripheral helper cells was associated with the development of the lymphoplasmacytic microenvironment. The refined immunosubtype could predict clinical outcomes of resectable HCC after surgery and unresectable HCC after Atezo + Bev therapy. The immune microenvironment of metastatic lesions tended to reflect those of primary lesions. Conclusions: We revealed the spatial dynamics of T- and B-cell responses in HCC, which is closely associated with the clinical outcome after surgical resection or Atezo + Bev therapy.

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Prognostic utility of the modified albumin-bilirubin score among patients undergoing curative-intent surgery for gallbladder cancer.

Chatzipanagiotou OP, Tsilimigras DI, Catalano G, Ruzzenente A, Aucejo F, Marques HP, Lam V, Bhimani N, Maithel SK, Endo I, Kitago M, Pawlik TM

Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract 28 （ 12 ） 2075 - 2083 2024年12月

ISSN 1091-255X

Background: Gallbladder cancer (GBC) has been associated with high rates of recurrence and dismal prognosis even after curative-intent resection. The prognostic utility of the modified albumin-bilirubin (mALBI) score among individuals undergoing curative-intent resection for GBC has not been determined. Methods: Patients who underwent radical resection for GBC between 2000 and 2022 were identified from an international, multi-institutional database. Preoperative albumin and bilirubin levels were used to calculate the mALBI score. The relationship among mALBI score, overall survival (OS), and recurrence-free survival (RFS) was examined. Results: Among 269 patients who underwent radical resection for GBC, 161 (59.9%) had mALBI grade 1, 48 (17.8%) had grade 2a, 47 (17.5%) had grade 2b, and 13 (4.8%) had mALBI grade 3. After surgery, compared with patients with a low mALBI grade (grade 1/2a), individuals with a high mALBI grade (grade 2b/3) had worse 5-year OS (54.4% vs 19.2%, respectively; P < .001) and RFS (42.0% vs 17.8%, respectively; P < .001). On multivariable analysis, after controlling for relevant clinicopathologic variables, individuals with a high mALBI score remained independently associated with higher risks of death and recurrence (OS: hazard ratio [HR], 2.38 [95% CI, 1.50–3.79]; RFS: HR, 2.12 [95% CI 1.41–3.20]) versus patients with a low mALBI score after curative-intent resection for GBC. Of note, mALBI score was associated with incrementally worse survival within T2, T3, and N+ categories, whereas classic American Joint Committee on Cancer subclassifications failed to distinguish patients with long-term survival. Conclusion: The mALBI score presents a simple, objective measure of hepatic functional reserve and may be a useful prognostic tool for patients undergoing curative-intent resection for GBC.

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Prognostic value of the advanced lung cancer inflammation index in intrahepatic cholangiocarcinoma.

Catalano G, Alaimo L, Chatzipanagiotou OP, Ruzzenente A, Aucejo F, Marques HP, Lam V, Hugh T, Bhimani N, Maithel SK, Kitago M, Endo I, Martel G, Pulitano C, Shen F, Popescu I, Koerkamp BG, Bauer TW, Cauchy F, Poultsides GA, Weiss M, Gleisner A, Pawlik TM

European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology 50 （ 12 ） 108773 2024年12月

ISSN 0748-7983

Introduction: The advanced lung cancer inflammation index (ALI), which combines inflammation and nutrition data, was recently proposed as a prognostic biomarker. We assessed the impact of ALI on overall survival (OS) among patients undergoing surgery for intrahepatic cholangiocarcinoma (ICC). Methods: Patients who underwent surgery for ICC were identified from an international cohort. ALI was calculated as body-mass index (BMI)∗albumin/neutrophil-to-lymphocyte ratio; patients were categorized into “low-” and “high-ALI” using log-rank statistics. The impact of ALI on OS was compared against other inflammatory markers (i.e., neutrophil-to-lymphocyte ratio [NLR], platelet-to-lymphocyte ratio [PLR], systemic immune inflammation index [SII = platelets∗NLR]) using Harrell's Concordance index (C-index) and the Akaike Information Criterion (AIC). To minimize intergroup differences, propensity score matching was employed. Results: Among 1045 patients, more than one-half of individuals underwent major hepatectomy (n = 582, 55.7 %), median tumor size was 5.5 cm (IQR, 3.8–7.8), and median ALI was 38.9 (IQR 26.5–57.2). On multivariate analysis, low ALI was an independent risk factor for worse OS (HR 1.21, 95 % CI 1.01–1.46; p = 0.04). Patients with low ALI had worse 5-year OS (36.9 % vs. 49.9 %; p < 0.001), which remained significant after PSM (36.9 % vs. 41.3 %; p = 0.039). ALI had a comparable discriminatory ability compared with NLR, PLR, and SII (C-index: 0.646 vs. 0.644 vs. 0.640 vs. 0.641, respectively), yet had a lower AIC (5475.31 vs. 5546.80 vs. 5550.45 vs. 5548.62, respectively) suggesting slightly better model fit and accuracy. Conclusions: ALI was an independent predictor of OS among patients undergoing surgery for ICC. Nutritional and inflammatory markers should be incorporated into predictive models to improve prognostic stratification.

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Recurrence Timing and Risk Following Curative Resection of Colorectal Liver Metastases: Insights From a Hazard Function Analysis.

Kawashima J, Akabane M, Endo Y, Woldesenbet S, Altaf A, Ruzzenente A, Popescu I, Kitago M, Poultsides G, Sasaki K, Aucejo F, Sahara K, Endo I, Pawlik TM

Journal of surgical oncology 2024年11月

ISSN 0022-4790

Introduction: There is no consensus on the optimal surveillance interval for patients undergoing resection of colorectal liver metastases (CRLM). We sought to assess the timing and intensity of recurrence following curative-intent resection of CRLM utilizing a recurrence-free survival (RFS) hazard function analysis. Methods: Patients with CRLM who underwent curative-intent resection were identified from a multi-institutional database. The RFS hazard function was used to plot hazard rates and identify the peak of recurrence over time. Results: Among 1804 patients, the median RFS was 19.9 months. In the analytic cohort, the RFS hazard curve peaked at 5.9 months (peak hazard rate: 0.054) and gradually declined, indicative of early recurrence. In subgroup analyses, patients with high and medium tumor burden scores (TBS) had RFS hazard peaks at 4.9 months (peak hazard rate: 0.060) and 5.8 months (peak hazard rate: 0.054), respectively. In contrast, patients with low TBS had a later peak at 7.5 months, with the lowest peak hazard rate of 0.047. Conclusions: The recurrence peak for CRLM patients occurred approximately 6 months postsurgery, highlighting the need for intensified early postoperative surveillance. Patients with high TBS experienced earlier recurrence, underscoring the importance of close monitoring, particularly during the first 6 months after surgery.

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Improved survival of pediatric deceased donor liver transplantation recipients after introduction of the pediatric prioritization system: Analysis of data from a Japanese national survey

Takemura Y., Shinoda M., Kasahara M., Sakamoto S., Hatano E., Okamoto T., Ogura Y., Sanada Y., Matsuura T., Ueno T., Obara H., Soejima Y., Umeshita K., Eguchi S., Kitagawa Y., Egawa H., Ohdan H., Ogawa E., Ito T., Sakuma Y., Yoshizumi T., Eguchi H., Shimamura T., Mita A., Hibi T., Fukumoto T., Hasegawa K., Marubashi S., Umeda Y., Nobori S., Hasegawa Y., Yamada Y., Kitago M.

Journal of Hepato-Biliary-Pancreatic Sciences 31 （ 11 ） 782 - 797 2024年11月

ISSN 18686974

Background: In Japan, there has never been a national analysis of pediatric deceased donor liver transplantation (pDDLT) based on donor and recipient factors. We constructed a Japanese nationwide database and assessed outcomes of pDDLT focusing on the pediatric prioritization system introduced in 2018. Methods: We collected data on pDDLTs (<18 years) performed between 1999 and 2021 from the Japan Organ Transplant Network and Japanese Liver Transplantation Society, identified risk factors for graft survival and compared the characteristics and graft survival in pDDLTs conducted before and after the introduction of the pediatric prioritization system. Results: Overall, 112 cases of pDDLT were included, with a 1-year graft survival rate of 86.6%. Four poor prognostic factors were identified: recipient intensive care unit stay, model for end-stage liver disease/pediatric end-stage liver disease score, donor cause of death, and donor total bilirubin. After the introduction of the system, allografts from pediatric donors were more reliably allocated to pediatric recipients and the annual number of pDDLTs increased. The 1-year graft survival rate improved significantly as did pDDLT conditions indicated by the risk factors. Conclusions: Under the revised allocation system, opportunities for pDDLT increased, resulting in favorable recipient and donor conditions and improved survival.

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Prognosis prediction of PDAC via detection of O-glycan altered extracellular vesicles in perioperative sera.

Uemura S, Kabe Y, Kitago M, Matsuda S, Abe Y, Hasegawa Y, Hori S, Tanaka M, Nakano Y, Sato Y, Itonaga M, Ono M, Kawakami T, Suematsu M, Kitagawa Y

Cancer science 115 （ 11 ） 3718 - 3728 2024年11月

ISSN 1347-9032

Pancreatic ductal adenocarcinoma (PDAC) is a fatal malignancy due to the difficulty in diagnosis and poor prognosis because of the high recurrence rate, necessitating reliable biomarkers to improve the diagnosis and prognosis. However, the existing markers have limitations. We previously identified extracellular vesicles (EVs) recognized by O-glycan-binding lectins (Amaranthus caudatus agglutinin [ACA]) as a novel diagnostic biomarker for PDAC using an EV-counting system (ExoCounter). This retrospective study analyzed changes in ACA-positive EVs in perioperative PDAC serum and its association with prognosis using ExoCounter. Absolute EV levels in the pre- and postoperative sera of 44 patients who underwent curative pancreatectomy for PDAC were quantified using ExoCounter. The carbohydrate antigen 19-9 levels declined in most samples postoperatively, and presented no correlation with poor prognosis. In contrast, ACA-positive EVs increased in serum at 7 days postoperatively in 27 of 44 patients (61.4%). We therefore divided participants with ACA-positive EVs before and after surgery into elevation and decline groups. The overall survival (OS) and recurrence-free survival (RFS) of patients with higher ACA-positive EVs were significantly shorter than those with lower ACA-positive EVs (26.1 months vs. not reached, P = 0.018; 11.9 vs. 38.6 months, P = 0.013). Multivariable analysis revealed that ACA-positive EV elevation in postoperative serum was an independent prognostic factor for poor OS (hazard ratio [HR] = 3.891, P = 0.023) and RFS (HR = 2.650, P = 0.024). The detection of ACA-positive EVs in perioperative serum may be used to predict the prognosis of PDAC in the early postoperative period.

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Preoperative identification of early extrahepatic recurrence after hepatectomy for colorectal liver metastases: A machine learning approach.

Kawashima J, Endo Y, Woldesenbet S, Chatzipanagiotou OP, Tsilimigras DI, Catalano G, Khan MMM, Rashid Z, Khalil M, Altaf A, Munir MM, Guglielmi A, Ruzzenente A, Aldrighetti L, Alexandrescu S, Kitago M, Poultsides G, Sasaki K, Aucejo F, Endo I, Pawlik TM

World journal of surgery 48 （ 11 ） 2760 - 2771 2024年11月

ISSN 0364-2313

Background: Machine learning (ML) may provide novel insights into data patterns and improve model prediction accuracy. The current study sought to develop and validate an ML model to predict early extra-hepatic recurrence (EEHR) among patients undergoing resection of colorectal liver metastasis (CRLM). Methods: Patients with CRLM who underwent curative-intent resection between 2000 and 2020 were identified from an international multi-institutional database. An eXtreme gradient boosting (XGBoost) model was developed to estimate the risk of EEHR, defined as extrahepatic recurrence within 12 months after hepatectomy, using clinicopathological factors. The relative importance of factors was determined using Shapley additive explanations (SHAP) values. Results: Among 1410 patients undergoing curative-intent resection, 131 (9.3%) patients experienced EEHR. Median OS among patients with and without EEHR was 35.4 months (interquartile range [IQR] 29.9–46.7) versus 120.5 months (IQR 97.2–134.0), respectively (p < 0.001). The ML predictive model had c-index values of 0.77 (95% CI, 0.72–0.81) and 0.77 (95% CI, 0.73–0.80) in the entire dataset and the validation data set with bootstrapping resamples, respectively. The SHAP algorithm demonstrated that T and N primary tumor categories, as well as tumor burden score were the three most important predictors of EEHR. An easy-to-use risk calculator for EEHR was developed and made available online at: https://junkawashima.shinyapps.io/EEHR/. Conclusions: An easy-to-use online calculator was developed using ML to help clinicians predict the chance of EEHR after curative-intent resection for CRLM. This tool may help clinicians in decision-making related to treatment strategies for patients with CRLM.

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Machine learning models including preoperative and postoperative albumin-bilirubin score: short-term outcomes among patients with hepatocellular carcinoma.

Endo Y, Tsilimigras DI, Munir MM, Woldesenbet S, Guglielmi A, Ratti F, Marques HP, Cauchy F, Lam V, Poultsides GA, Kitago M, Alexandrescu S, Popescu I, Martel G, Gleisner A, Hugh T, Aldrighetti L, Shen F, Endo I, Pawlik TM

HPB : the official journal of the International Hepato Pancreato Biliary Association 26 （ 11 ） 1369 - 1378 2024年11月

ISSN 1365-182X

Background: We sought to assess the impact of various perioperative factors on the risk of severe complications and post-surgical mortality using a novel maching learning technique. Methods: Data on patients undergoing resection for HCC were obtained from an international, multi-institutional database between 2000 and 2020. Gradient boosted trees were utilized to construct predictive models. Results: Among 962 patients who underwent HCC resection, the incidence of severe postoperative complications was 12.7% (n = 122); in-hospital mortality was 2.9% (n = 28). Models that exclusively used preoperative data achieved AUC values of 0.89 (95%CI 0.85 to 0.92) and 0.90 (95%CI 0.84 to 0.96) to predict severe complications and mortality, respectively. Models that combined preoperative and postoperative data achieved AUC values of 0.93 (95%CI 0.91 to 0.96) and 0.92 (95%CI 0.86 to 0.97) for severe morbidity and mortality, respectively. The SHAP algorithm demonstrated that the factor most strongly predictive of severe morbidity and mortality was postoperative day 1 and 3 albumin-bilirubin (ALBI) scores. Conclusion: Incorporation of perioperative data including ALBI scores using ML techniques can help risk-stratify patients undergoing resection of HCC.

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Machine learning prediction of early recurrence after surgery for gallbladder cancer.

Catalano G, Alaimo L, Chatzipanagiotou OP, Ruzzenente A, Aucejo F, Marques HP, Lam V, Hugh T, Bhimani N, Maithel SK, Kitago M, Endo I, Pawlik TM

The British journal of surgery 111 （ 11 ） 2024年10月

ISSN 0007-1323

Background: Gallbladder cancer is often associated with poor prognosis, especially when patients experience early recurrence after surgery. Machine learning may improve prediction accuracy by analysing complex non-linear relationships. The aim of this study was to develop and evaluate a machine learning model to predict early recurrence risk after resection of gallbladder cancer. Methods: In this cross-sectional study, patients who underwent resection of gallbladder cancer with curative intent between 2001 and 2022 were identified using an international database. Patients were assigned randomly to a development and an evaluation cohort. Four machine learning models were trained to predict early recurrence (within 12 months) and compared using the area under the receiver operating curve (AUC). Results: Among 374 patients, 56 (15.0%) experienced early recurrence; most patients had T1 (51, 13.6%) or T2 (180, 48.1%) disease, and a subset had lymph node metastasis (120, 32.1%). In multivariable Cox analysis, resection margins (HR 2.34, 95% c.i. 1.55 to 3.80; P < 0.001), and greater AJCC T (HR 2.14, 1.41 to 3.25; P < 0.001) and N (HR 1.59, 1.05 to 2.42; P = 0.029) categories were independent predictors of early recurrence. The random forest model demonstrated the highest discrimination in the evaluation cohort (AUC 76.4, 95% c.i. 66.3 to 86.5), compared with XGBoost (AUC 74.4, 53.4 to 85.3), support vector machine (AUC 67.2, 54.4 to 80.0), and logistic regression (AUC 73.1, 60.6 to 85.7), as well as good accuracy after bootstrapping validation (AUC 75.3, 75.0 to 75.6). Patients classified as being at high versus low risk of early recurrence had much worse overall survival (36.1 versus 63.8% respectively; P < 0.001). An easy-to-use calculator was made available (https://catalano-giovanni.shinyapps.io/GallbladderER). Conclusion: Machine learning-based prediction of early recurrence after resection of gallbladder cancer may help stratify patients, as well as help inform postoperative adjuvant therapy and surveillance strategies.

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Novel procedure for hepatic venous outflow block after liver resection: A case report.

Higashi H, Abe Y, Abe K, Nakano Y, Tanaka M, Hori S, Hasegawa Y, Yagi H, Kitago M, Kitagawa Y

World journal of clinical cases 12 （ 29 ） 6320 - 6326 2024年10月

ISSN 2307-8960

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The efficacy of wrapping with polyglycolic acid mesh and fibrin glue in preventing clinically relevant pancreatic fistula after minimally invasive distal pancreatectomy (WRAP Study): study protocol for a multicenter randomized controlled trial in Japan.

Baba H, Oba A, Tanaka K, Miura T, Ban D, Edanami M, Ishikawa Y, Ohgi K, Tanaka H, Shintakuya R, Ikenaga N, Ijichi T, Kiya Y, Muranushi R, Yamaki S, Miyazaki N, Takeuchi S, Aoki S, Mizui T, Tanaka M, Ueda H, Dei H, Takami H, Okada K, Nakata K, Mataki Y, Osakabe H, Shibuya K, Hashimoto D, Inoue Y, Hirano S, Unno M, Esaki M, Kitago M, Akahoshi K, Sugiura T, Ebata T, Uemura K, Nakamura M, Otsuka T, Nagakawa Y, Fujii T, Satoi S, Takahashi Y

BMC surgery 24 （ 1 ） 314 2024年10月

Background: Postoperative pancreatic fistula (POPF) continues to be the most common complication after distal pancreatectomy (DP). Recent advancements in surgical techniques have established minimally invasive distal pancreatectomy (MIDP) as the standard treatment for various conditions, including pancreatic cancer. However, MIDP has not demonstrated a clear advantage over open DP in terms of POPF rates, indicating the need for additional strategies to prevent POPF in MIDP. This trial (WRAP study) aims to evaluate the efficacy of wrapping the pancreatic stump with polyglycolic acid (PGA) mesh and fibrin glue in preventing clinically relevant (CR-) POPF following MIDP. Methods: This multicenter, randomized controlled trial will include patients scheduled for laparoscopic or robotic DP for tumors in the pancreatic body and/or tail. Eligible participants will be centrally randomized into either the control group (Group A) or the intervention group (Group B), where the pancreatic stump will be reinforced by PGA mesh and fibrin glue. In both groups, pancreatic transection will be performed using a bioabsorbable reinforcement-attached stapler. A total of 172 patients will be enrolled across 14 high-volume centers in Japan. The primary endpoint is the incidence of CR-POPF (International Study Group of Pancreatic Surgery grade B/C). Discussion: The WRAP study will determine whether the reinforcement of the pancreatic stump with PGA mesh and fibrin glue, a technique whose utility has been previously debated, could become the best practice in the era of MIDP, thereby enhancing its safety. Trial registration: This trial was registered with the Japan Registry of Clinical Trials on June 15, 2024 (jRCTs032240120).

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